BReast CAncer Genes(BRCA) Expressions in Metastatic Gastric Cancer
A Pilot Trial of Platinum Based Chemotherapy According to BRCA Expressions as First-line Chemotherapy in Patients With Metastatic Gastric Cancer
1 other identifier
interventional
30
1 country
1
Brief Summary
The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis according to BRCA loss. And the investigators evaluated the possibility of BRCA loss as a predictive and prognostic factor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
February 7, 2019
CompletedFirst Posted
Study publicly available on registry
February 12, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedJanuary 27, 2021
January 1, 2021
2.4 years
February 7, 2019
January 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective response rate
the proportion of patients who have a partial or complete response to therapy; it does not include stable disease and is a direct measure of drug tumoricidal activity.
through study completion, an average of 1 year
Secondary Outcomes (2)
Progression free survival
through study completion, an average of 1 year
Overall survival
through study completion, an average of 1 year
Study Arms (2)
BRCA1 positive
EXPERIMENTALFOLFOX or CAPOX Chemotherapy FOLFOX : Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days. CAPOX: Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.
BRCA1 negative
ACTIVE COMPARATORFOLFOX or CAPOX Chemotherapy FOLFOX : Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + 5-FU 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days. CAPOX: Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.
Interventions
The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis.
FOLFOX : Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days. CAPOX: Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days.
Eligibility Criteria
You may qualify if:
- Metastatic gastric cancer( Adenocarcinoma)
- Eastern Cooperative Oncology Group (ECOG) performance 0-2
- one more measure lesion
- White blood cell count (WBC) \> 3000/ul , Platelet \> 75,000/ul
- Normal kidney function (serum creatinine \< 1.5 ULN)
- Normal Liver function (Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) \< 3 times of upper normal limit, if liver metastasis, AST/ALT \< 5 times of upper normal limit)
- life expectancy is more than 3 months
- Conventional surgery that does not cause the transformation of the target lesion is allowed
- The patient who voluntarily decided to participate in this study and agreed in writing
You may not qualify if:
- Her-2 positive advanced gastric cancer
- Central nervous system metastases requiring treatment with symptoms
- Major uncontrolled cardiovascular disease (including myocardial infarction and congestive heart failure within 6 months)
- Uncontrolled infection or other serious diseases
- Patients with serious medical conditions or serious illnesses
- Patient who is pregnant or lactating
- Adjuvant chemotherapy before 6 months (patients who have not received platinum-based chemotherapy even if they are 6 months old can register)
- In the past, if the primary lesion or target lesion was treated with radiation (if the recurred lesion is outside the range of radiation therapy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chung-Ang University College of Medicine
Seoul, 06973, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
In Gyu Hwang
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 7, 2019
First Posted
February 12, 2019
Study Start
August 1, 2017
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
January 27, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share